Edwards Lifesciences boosts outlook after Street-beating Q1

Edwards Lifesciences (NYSE:EW) yesterday boosted its outlook after posting 1st-quarter numbers that beat expectations on Wall Street, with CEO Mike Mussallem saying the FDA could approve an intermediate-risk indication for its Sapien 3 heart valve this year.

The Irvine, Calif.-based company reported profits of $143.0 million, or 66¢ per share, on sales of $697.3 million for the 3 months ended March 31, marking a 15.9% bottom-line gain on sales growth of 18.1% compared with Q1 2015. Adjusted to exclude 1-time items, earnings per share were 71¢, ahead of the Street’s forecast for 66¢.

EW shares, which have gained 20% since it released strong data on the intermediate risk cohort earlier this month, closed up 0.8% at $108.83 yesterday and gained another 1.3% in after-hours trading, rising to $110.25 apiece.

“We remain on track to submit the final intermediate risk data sets to the FDA in the next couple of weeks. Based on the strength of these data, it’s possible for the approval for the approval to come earlier than expected, although it’s difficult to predict regulatory timelines. We are now modeling an approval and launch at the beginning of the 4th quarter,” Mussallem told analysts during a conference call yesterday. “Remember that this is a product that’s already approved and in the hands of hospitals. So given that that’s the case this is only an indication expansion. We will be training our team and our sites on how to handle that to make sure that they indicate the proper patients for this, but other that we expect to be ready for the launch. With big production increase of course that’s a bit of a strain on our manufacturing operations but we expect to be able to handle all that.”

Edwards said it now expects to post 2016 adjusted EPS of $2.67 to $2.77, 10¢ ahead of its prior forecast, and raised its sales outlook to $2.7 billion to $3 billion, up from $2.6 billion to $2.85 billion previously.

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